Regulatory Manager (Labeling Devices) - Temporary

• Provide advice and counsel on EU MDR, device labeling and global translation process, communicating closely with impacted stakeholders.
• Responsible for ensuring compliance with the SmPC & other labeling requirements for Summary of Product Characteristics (SmPC) and related patient insert and labeling (PI Annex I-III) for pharmaceutical products in Europe for assigned products.
• Ensure alignment of overall key labeling statements and key messages across EU labeling documents for assigned products.
• Ensure consistency of EU device and drug product labeling across assigned product lines and compliance with AbbVie policies and procedures.
• Review/QC materials, author documents, meet submission timelines for assigned products including rapid response label/PI authoring and/or review.
• In collaboration with other Global Labeling team members, analyze competitor labeling for products in same class to ensure AbbVie products have most competitive labeling. Maintain awareness of recent competitor approvals in class/region for assigned products.
• Agree timelines for submission and implementation of drug product or device label changes through interface with RA Area product owners, Brand managers, supply chain, Global Label Management (GLM) and other functions as required.
• Maintain active awareness of all relevant EU legislation and guidance relevant to EU devices / product information/ labeling and assess impact on AbbVie business and R&D programs, in collaboration with RPI.
• Provide information for artwork briefs for EU, for device and drug product production artwork describe and communicate content and agreed timelines of changes to affiliates & GLM, provide master mock-ups/word documents to enable redlining in the EU. Present updates/forecasts to affiliates/LCC and other stakeholders at regular (bi-weekly) affiliate meetings for assigned products/devices.

• Lead or support project work related to device labeling improvements or compliance or systems.
• Support inspection readiness activities for assigned products.
• Lead readability testing strategy for assigned products – including drafting bridge tests when needed and vendor management where required.
• Take responsibility for device website maintenance for assigned products where applicable.
• Manage the device labeling in the RIM system, including routing and approvals.
• Support and provide guidance for other team members and products when required.
• External representation for device labeling topics.

• 5-7 years in Regulatory, R&D or related area, 3 years in Regulatory preferred with experience in regulatory affairs device / drug product labeling or equivalent experience within the pharmaceutical medical device industry, European experience required.

• A solid working knowledge of device labeling process is highly desirable. Candidates must be able to demonstrate strong project management, problem solving, strategic thinking, negotiation, interpersonal and communication skills (both written and oral). Strong team mindset.

• Competent knowledge of and demonstrated ability to apply EU regulatory guidelines pertaining to device and drug product labeling. Must be able to work independently and be flexible with meetings on different time zones at both ends of the working day.

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